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BACKGROUND: Several comparison studies have demonstrated that endoscopic sphincterotomy (EST) combined with large-balloon dilation (LBD) may be a better option than EST alone to manage large bile duct stones. However, limited data were available to compare this combination method with LBD alone in removal of large bile duct stones. OBJECTIVE: To compare EST plus LBD and LBD alone for the management of large bile duct stones, and analyze the outcomes of each method. PATIENTS AND METHODS: Sixty-one patients were included in the EST plus LBD group, and 48 patients were included in the LBD alone group retrospectively. The therapeutic success, clinical characteristics, procedure-related parameters and adverse events were compared. RESULTS: Compared with EST plus LBD, LBD alone was more frequently performed in patients with potential bleeding diathesis or anatomical changes (P = 0.021). The procedure time from successful cannulating to complete stone removal was shorter in the LBD alone group significantly (21.5 vs. 17.3 min, P = 0.041). The EST plus LBD group and the LBD alone group had similar outcomes in terms of overall complete stone removal (90.2% vs. 91.7%, P = 1.000) and complete stone removal without the need for mechanical lithotripsy (78.7% vs. 83.3%, P = 0.542). Massive bleeding occurred in one patient of the EST plus LBD group, and successfully coagulated. Postoperative pancreatitis did not differ significantly between the EST plus LBD group and the LBD alone group (4.9% vs. 6.3%; P = 1.000). CONCLUSION: Endoscopic sphincterotomy combined with LBD offers no significant advantage over LBD alone for the removal of large bile duct stones. LBD can simplify the procedure compared with EST plus LBD in terms of shorten the procedure time. [ABSTRACT FROM AUTHOR]